Dallas Fort Worth Injury Lawyer Blog
Exactech Knee Failure Lawsuits. In this article, I am going to highlight the problems with the Exactech brand of knee implants, the status of the lawsuits, and what an affected victim can do to receive compensation for having a defective knee in the first place and then to undergo painful expensive revision surgery within a short time frame.
Exactech Knee Failure Lawsuits. Having a defective Exactech knee implant can cause serious pain and the need for early revision. Injured? Call Dr. Malik Law Firm 214-390-3189
Bear with me, it is going to be a bumpy ride!
Exactech Knee Failure? Dr. Shezad Malik Law Firm can help
The Dr. Shezad Malik Law Firm is accepting Exactech knee failure, ankle implant, and hip implant failure cases in all 50 states. If you or a loved one have a defective Exactech ankle, hip, or knee implant contact us immediately for a free consultation.
Who is Exactech?
Exactech is a company that specializes in developing, manufacturing, distributing, and selling orthopedic implant devices, along with related surgical instrumentation and biologic services for hospitals and physicians. Founded in 1985 and headquartered in Gainesville, Florida, USA.
What is the Exactech Recall?
The Exactech knee recall was issued due to issues with the packaging of several of its knee, ankle, and hip replacement devices, which could lead to early degradation of the components.
The problematic packaging lacked an essential oxygen barrier layer, leading to increased risk of oxidation of the polyethylene inserts before implantation. This oxidation could result in early and excessive device wear, component fracture, device failure, new or worsening pain, more bone loss, swelling in the affected area, or the need for revision surgery.
The FDA in March 2023 issued a warning communication regarding the Risks with Exactech Joint Replacement Devices with Defective Packaging.
Exactech has recalled 147,000+ defective joint replacement products (Hip, Knee, Ankle). The FDA has classified this as a Class II recall, meaning that exposure to the product may cause temporary or medically reversible health consequences.
The recall specifically expanded on February 7, 2022, to include all Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements packaged in these defective bags, regardless of a device’s label or shelf life. It was found that about 80% of the knee and ankle replacement devices manufactured since 2004 were affected by this packaging issue.
The recalled products cover a wide range of Exactech’s knee and ankle replacement components, including various models of Tibial Inserts and Components across the Optetrak, Optetrak Logic, Truliant, and Vantage lines.
Exactech Implant Recall Federal and State Court Lawsuits
The Exactech litigation has been centralized in a multidistrict ligation MDL, because of the common questions of fact and law alleged in the complaints filed throughout the federal court system. The MDL consolidation pretrial proceedings have been established before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, for coordinated discovery and pretrial proceedings. The first bellwether trials are scheduled to take place in mid 2025.
Judge Donna Keim of the Eighth Judicial Circuit is currently overseeing the Exactech lawsuits in Florida state court, and has previously indicated that the first case will go to trial in the state in October 2024.
Exactech is exposed to more than 1,200 product liability and personal injury lawsuits throughout the federal court system, with more than 400 additional injury cases spread across different state courts nationwide, each noting similar allegations that the Exactech’s manufacturing defects caused the joint implants to fail prematurely.
What are the recommendations for an Exactech device problem?
Patients who have had surgery using Exactech’s Optetrak, Truliant, or Vantage knee, ankle, and hip replacements should see their doctor regularly for monitoring, even if they are not experiencing symptoms. Routine examinations and X-rays are recommended to check for potential device failure.
If you have an Exactech implant and are experiencing new or worsening knee pain, swelling, pain while walking, knee instability, grinding, clicking, or other noises from the knee implant, you should report these issues to your surgeon immediately. The surgeon may recommend revision surgery to remove or replace the components if the polyethylene insert fails.
Exactech Knee Failure Example Case
A Maine woman filed a product liability and personal injury lawsuit claiming that her Exactech knee devices, implanted 2012, was defective and caused permanent and debilitating injuries because of premature knee failure.
She underwent a right total knee replacement in January 2012, and a left total knee replacement in October 2012 in Lewiston, Maine.
The Exactech Knee Device implanted during the surgeries included various components such as the Exactech Tibial Insert, Tibial Tray, and Femoral Component. In 2018, she needed painful revision surgery because the polyethylene liner wore out with resulting bone loss, loosening of the tibial component, and the unfortunate development of complex regional pain syndrome.
The woman is debilitated by constant knee pain and knee aches, walking impairment, poor balance, and other serious mobility issues.
How did we get into this mess with Optetrak Knee Implants?
The Optetrak knee implant system was approved with the fast track 501(k) FDA clearance process, meaning that the device was never subject to a full FDA in-depth review and go through the strict approval process. Basically the Optetrak device approval was a rubber stamped fiasco. The Optetrak implant system has been plagued by abnormally high failure rates.
According to an article published in 2012, in the journal Orthopedics and Traumatology the report noted “poor results” in the Optetrak knee replacement systems and suggested it was related to a design flaw.
In 2016, the Australian Registry, an internationally recognized orthopedic implant registry, found that the Optetrak with a higher-than-expected revision rate. The Optetrak device was found to have the worst failure rates among all knee replacement implants at five years (6.6%), seven years (7.9%), and ten years (9.6%).
Injured by an Exactech Implant Device?
Anyone who had knee replacement surgery with an Exactech implant system can file a personal injury and product liability lawsuit and get financial compensation for pain and suffering, medical expenses, and lost income resulting from their implant failure.
We are actively seeking Exactech knee implant recall cases from patients impacted by a defective Exactech knee implant system, including the Opetetrak® or Truliant® knee replacement systems. Contact us about filing an Exactech knee implant lawsuit.
EXACTECH KNEE RECALL LAWSUITS. Did you or a loved one experience problems with an Exactech Optetrak, Optetrak Logic or Truliant knee replacement? Dr. Shezad Malik law firm based in Dallas, Texas is now reviewing Exactech knee implant failure and revision cases nationwide. Please call 214-390-3189 or email us for further information.
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